NCT04092010

Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 388 (estimated)
• Sponsor: Brown University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.

Detailed description

This research study is a community-based efficacy trial (n=388) of a stepped-care model intervention to strengthen the capacity of Head Start to address parental depression and related adversities. Head Start mothers with symptoms of depressed mood or anhedonia, and their Head Start children, are enrolled across 12 Head Start centers. The research study aims to improve developmental outcomes for Head Start children by delivering stepped care intervention that incorporates depression prevention and linkage to formal mental health care to mothers. Mothers with low baseline depressive symptoms are offered a problem-solving intervention while mothers with greater symptoms are offered engagement sessions to link them to formal mental health services. At each problem-solving session participant's symptoms are assessed and if the symptoms meet pre-specified 'step-up' criteria, they are converted to Engagement sessions. Over 12 months, the intervention's effect will be assessed on a series of outcome measures for mothers; mechanisms by which maternal depression is theorized to impact young children; and child outcomes.

Conditions

• Maternal Depression

Interventions

Type	Name	Description
BEHAVIORAL	Problem-solving education (PSE)	PSE will be offered to mothers with low baseline depressive symptoms (the first, preventive step of the SCI). PSE participants will have their symptoms assessed at each session and will convert to Engagement Sessions if they meet pre-specified 'step up' criteria.
BEHAVIORAL	Engagement sessions	Engagement sessions will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI)
BEHAVIORAL	Usual care	Normal services provided children and their mothers in Head Start

Timeline

• Start date: 2023-08-16
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2019-09-17
• Last updated: 2024-12-11

Locations

1 site across 1 country: United States